About us
Polbionica is an innovative biotechnology company developing the 3D Bionic Pancreas – ATMP® and delivering key technologies that drive the advancement of 3D bioprinting.
Polbionica S.A. is a Polish biotech spin-off originating from a team of scientists at the Foundation on Research and Science Development. In 2019, the research group led by prof. Michał Wszoła developed the world’s first successful prototype of a fully functional, vascularized bionic pancreas created using 3D bioprinting technology.
Polbionica continues to advance this breakthrough technology with the goal of commercializing the bionic pancreas as a therapeutic solution for patients with type 1 diabetes and chronic pancreatitis. The company has successfully completed preclinical studies and is currently preparing to initiate clinical trials.
Our mission is to develop innovative medical biotechnology, 3D bioprinting, and biomaterials technologies that improve patient health and quality of life worldwide. We operate in compliance with international quality standards, including ISO 13485, as well as applicable regulations for medical devices and advanced therapy medicinal products (ATMPs).
We pursue this mission through commercialization of scientific research and the development of bioprinted organs, organoids, tissue models, and biomaterials used in transplantology, regenerative medicine, preclinical research, and drug discovery.
Our vision is to bring 3D bioprinting technologies into routine clinical practice worldwide. We believe the bionic pancreas has the potential to become a new standard of care for advanced type 1 diabetes and one of the landmark achievements of modern medicine.
Polbionica’s strategy also includes the development and commercialization of enabling technologies that support organ biofabrication, including the ResearchLine™ Bioreactor and proprietary bioinks with unique biological properties: TintBionic®, CleanCure™, and Printiss®.
Polbionica Quality Management System – ISO 13485 Certification and Commitment to Medical Innovation – Quality Policy
A key element in achieving Polbionica’s ambitious goals is the implementation and continuous improvement of a Quality Management System compliant with the international ISO 13485 standard.
On March 13, 2025, following a rigorous audit, United Registrar of Systems (URS) awarded Polbionica a certificate confirming that our Quality Management System complies with the ISO 13485 standard.
This certification is a testament to our continuous dedication to ensuring the safety, effectiveness, and reliability of our products — building trust among customers, partners, and medical institutions.
Polbionica declares full adherence to the implemented Quality Policy, which forms the foundation of our operations.
This policy encompasses a rigorous approach to the design, manufacturing, and testing of bioprinted products, ensuring their highest quality and compliance with stakeholder expectations.
Thanks to ISO 13485 certification and the continuous improvement of our processes, Polbionica is strengthening its position as a leader in the field of 3D bioprinting, contributing to the advancement of cutting-edge medical technologies in both the Polish and international markets.
Our team
Polbionica is an interdisciplinary, committed and open to challenges team.
Our team consists of doctors, medical consultants, biotechnologists, engineers and laboratory technicians, but also quality experts, business creators, specialists in… sales and administration. Together, we strive to improve the lives of patients with diabetes.
Prof. Michał Wszoła MD, PhD
Chief Executive Officer
Filip Fertner
Chief Financial Officer
Marta Klak PhD
Chief Technology Officer
Tomasz Bąkowski phd
Director of Clinical Affairs and Commercialization
What we are currently doing
Projects
Awards & Recognitions
European Commission – Seal of Excellence
Horizon Europe | EIC Accelerator (2023)
Horizon 2020 | SME Instrument (2020)
Project: 3D-bioprinted bionic pancreas as a cure for type 1 diabetes